Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease

Phase 4

Completed

• Conditions: Systemic Lupus; Sjögren Syndrome; Rheumatoid Arthritis; Systemic Vasculitis; Spondyloarthritis
• Interventions: Biological: 13-valent pneumococcal conjugate vaccine; Biological: 23-valent pneumococcal polysaccharide vaccine

• Registration Number: NCT03762824
• Lead Sponsor: Region Skane

Brief Summary

The overall objective of this project is to study the influence of modern anti-inflammatory treatments in established inflammatory rheumatic diseases (IRD) on antibody response elicited by pneumococcal vaccination using 13-valent conjugate vaccine in combined schedules with 23-valent polysaccharide vaccine. In addition, the aim is to study the clinical aspects of vaccination regarding: tolerability in immunosuppressed patients with IRD, impact on existing rheumatic disease, possible association with onset of new autoimmune diseases, long-term immunity following pneumococcal vaccination and efficacy in preventing invasive pneumococcal disease. Results from this study are expected to bridge the existing knowledge gap and contribute to body of evidence needed for recommendations and implementation of vaccination program in IRD patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-14
• Primary Completion: 2018-09-03
• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-04
• Study Completion: 2020-12-21
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Adult patients with IRD receiving active anti-rheumatic treatments with DMARDs or biological remedies are offered to participate in the study. The protocol permits stratification for prednisolone usage.

Exclusion Criteria

• known allergy/intolerance of pneumococcal vaccine
• pregnancy
• active infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCV13+PPV23 vaccinated patients	13-valent pneumococcal conjugate vaccine	Patients with different inflammatory rheumatic diseases are immunized with one dose 13-valent pneumococcal conjugate vaccine 0.5 ml i.m., followed by one dose 23-valent pneumococcal polysaccharide vaccine 0.5 ml i.m. after 8 weeks.
PPV23-booster to previous PCV-vaccinated controls	23-valent pneumococcal polysaccharide vaccine	Healthy controls previously immunized with one dose PCV7 or PCV13 within another study (see VACCIMIL), are immunized with one dose PPV23 0.5 ml i.m.
PCV13+PPV23 vaccinated patients	23-valent pneumococcal polysaccharide vaccine	Patients with different inflammatory rheumatic diseases are immunized with one dose 13-valent pneumococcal conjugate vaccine 0.5 ml i.m., followed by one dose 23-valent pneumococcal polysaccharide vaccine 0.5 ml i.m. after 8 weeks.
PPV23-booster to previous PCV-vaccinated patients	23-valent pneumococcal polysaccharide vaccine	Patients with different inflammatory rheumatic disease previously immunized with one dose PCV7 or PCV13 within another study (see VACCIMIL), are immunized with one dose PPV23 0.5 ml i.m.
PCV13 to previous PPV23-vaccinated patients	13-valent pneumococcal conjugate vaccine	Patients with different inflammatory rheumatic disease previously immunized with one dose PPV23 within another study (see VACCIMIL), are immunized with one dose PCV13 0.5 ml i.m.
PCV13+PPV23 vaccinated controls	13-valent pneumococcal conjugate vaccine	Healthy controls are immunized with one dose 13-valent pneumococcal conjugate vaccine 0.5 ml i.m., followed by one dose 23-valent pneumococcal polysaccharide vaccine 0.5 ml i.m. after 8 weeks.
PCV13+PPV23 vaccinated controls	23-valent pneumococcal polysaccharide vaccine	Healthy controls are immunized with one dose 13-valent pneumococcal conjugate vaccine 0.5 ml i.m., followed by one dose 23-valent pneumococcal polysaccharide vaccine 0.5 ml i.m. after 8 weeks.

Primary Outcome Measures

Name	Time	Method
2-fold rise in pneumococcal serotype-specific antibody concentration	8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination	Pneumococcal serotype-specific antibody concentration (12-valent)

Secondary Outcome Measures

Name	Time	Method
Long-term serotype-specific immunity to pneumococcal disease	3 years after vaccination	Pneumococcal serotype-specific antibody concentration
Functional antibody response	8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination	Opsonophagocytosis activity assay